Table 4.
Summary of the studies evaluating CLE in biliary disease screening and diagnosis (all “per patient” analysis).
| Author and year | Country | N | Mean age (yr) | Sensitivity (%) | Specificity (%) | PPV (%) | NPV (%) | Accuracy (%) | Main findings |
|---|---|---|---|---|---|---|---|---|---|
| Meining et al. 2008 [107] | Germany | 14 patients | 61.3 | 83 | 88 | / | / | 86 | p-CLE considerably increases sensitivity for the detection of biliary neoplasia and therefore represents a promising diagnostic approach. |
| Giovannini et al. 2011 [108] | France | 37 patients | 62.3 | 83 | 75 | n/a | n/a | 86 | Intrabiliary pCLE is feasible. |
| Meining et al. 2011 [109] | Germany USA |
89 patients | 62.8 | 98 | 67 | 71 | 97 | 81 | p-CLE provides reliable microscopic examination and has excellent sensitivity and NPV with significantly higher accuracy of ERCP and pCLE compared with ERCP with tissue acquisition. |
| Meining et al. 2012 [110] | Germany USA |
47 and 42 patients | 63.2 63 |
97 | 33 | 80 | 80 | n/a | The Miami Classification enables a structured, uniform, and reproducible description of pancreaticobiliary pCLE. |
| Shieh et al. 2012 [2] | USA | 10 patients | 56.9 | n/a | n/a | n/a | n/a | n/a | pCLE of the CBD via the GastroFlexUHD miniprobe is feasible and may offer improved image quality over the standard CholangioFlex probe. |
| Caillol et al. 2013 [111] | France USA |
60 patients | 62.2 | 96.3 | 75.7 | 76.5 | 96.2 | 85 | The Paris Classification improve the accuracy of pCLE for diagnosing benign inflammatory strictures. |
| Caillol et al. 2013 [112] | France | 54 patients | 66 | 88 | 83 | n/a | n/a | 87 | Inflammation from prestenting procedures interferes with pCLE diagnosis of the bile duct lesions. |
| Heif et al. 2013 [113] | USA | 15 patients | 54 | 100 | 61.1 | 22.2 | 100 | n/a | pCLE may have a high sensitivity and negative predictive value to exclude neoplasia in patients with PSC and DS. |
| Caillol et al. 2015 [114] | France | 61 patients | 67 | 88 | 79 | 92 | 69 | 85 | The addition of a pCLE procedure in the diagnostic histologic examination of a biliary stricture permits a significant increase in diagnostic reliability and allows for a VPN of 100%. |
| Slivka et al. 2015 [115] | USA Italy France |
112 patients | 64.5 | 89 | 71 | 93 | 82 | 88 | pCLE provided a more accurate and sensitive diagnosis of cholangiocarcinoma compared with tissue sampling alone. |
N stands for the number of patients enrolled in the study; pCLE, probe-based confocal laser endomicroscopy; CLE, confocal laser endomicroscopy; PPV, positive predictive value; NPV, negative predictive value; PSC, primary sclerosing cholangitis; DS, dominant biliary stricture; and CBD, common bile duct.